Erectile DysfunctionNCT05241964
Platelet-rich Plasma(PRP) Injection in ED
A study testing PRP in people with Erectile Dysfunction and PRP, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, PRP
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Mar 2021to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Between 20 and 70 years old
- Sexual dysfunction exists for at least 6 months
- IIEF-5 score 8-2
- Sign an informed consent form
Who cannot join
- Ever radical prostatectomy or extensive pelvic surgery
- Radiation therapy to the pelvic area within 12 months before recruiting
- Cancer
- Nervous system diseases that affect erectile function
- Have any blood disease
- History of coronary artery disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
I-NI CHIANG, MD, inichiang@gmail.com
+886919077219
About this study
Official title: A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment
RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.
Read the detailed description
There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.
- Conditions
- Erectile Dysfunction, PRP
- Being tested
- PRP
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
4~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | PRP injection Receives: Biological: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function(IIEF-5)
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild (12-21), and no ED (22-25).
Measured: Change from 0 week at 4,8,12,24,48 weeks
Secondary outcomes (3)
Erection Hardness Score(EHS)
EHS can be a helpful tool to evaluate ED - a man's inability to get or maintain an erection firm enough for sex. To select one of the following options:
0 Penis does not enlarge
- Penis is larger, but not hard
- Penis is hard, but not hard enough for penetration
- Penis is hard enough for penetration, but not completely hard
- Penis is completely hard and fully rigid
Measured: Change from 0 week at 4,8,12,24,48 weeks
Duplex - Peak systolic velocity(PSV)
To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)
Measured: 0,16 weeks
Duplex - Resistance index(RI)
To assess penile hemodynamics - Penile vascular resistance Index
Measured: 0,16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start22 Mar 2021
- Primary completion22 Sep 2022 (estimated)
- Study completion29 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Ni Chiang, MD, Principal investigator, Taipei Veteran General hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241964
- Sponsor's protocol ID
- 202008061RIPC
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment
- ClinicalTrials.gov ID
- NCT05241964
- Acronym / sponsor ID
- 202008061RIPC
- Conditions
- Erectile Dysfunction, PRP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 22 Sep 2022 (estimated)
- Study completion
- 29 Nov 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.
Detailed description
There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: PRPPRP injection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Between 20 and 70 years old
- Sexual dysfunction exists for at least 6 months
- IIEF-5 score 8-2
- Sign an informed consent form
Key exclusion criteria (6 listed)
- Ever radical prostatectomy or extensive pelvic surgery
- Radiation therapy to the pelvic area within 12 months before recruiting
- Cancer
- Nervous system diseases that affect erectile function
- Have any blood disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP4~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections. | Biological | PRP |
Primary outcome
International Index of Erectile Function(IIEF-5)
Time frame: Change from 0 week at 4,8,12,24,48 weeks
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild (12-21), and no ED (22-25).
3 secondary outcomes
Erection Hardness Score(EHS)
Time frame: Change from 0 week at 4,8,12,24,48 weeks
Duplex - Peak systolic velocity(PSV)
Time frame: 0,16 weeks
Duplex - Resistance index(RI)
Time frame: 0,16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Ni Chiang, MD principal investigator
Taipei Veteran General hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Erectile Dysfunction and PRP, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Ni Chiang, MD (+886919077219, inichiang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function(IIEF-5) (time frame: Change from 0 week at 4,8,12,24,48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.